biopharmaceutical manufacturing, new stuff!!!

Indian companies like Biocon, Bharat Biotech, Biological E, Serum Institute and Shantha Biotechnics have world-class facilities for biopharmaceutical manufacturing. Earlier there was some reluctance to award contracts to Asian biopharma manufacturers because of concerns of IP and regulatory compliance. But now some of the Asian countries are changing and becoming very competitive in biopharma manufacturing. "Indian firms are expanding and scaling up manufacturing capacities to become global players and the West is increasingly becoming comfortable with the IP, quality, regulatory filings and the infrastructure here," said Gautam Das, COO, Syngene.

Shasun Chemicals, Suven Life Sciences, Strides Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many other large Indian companies have started undertaking contract manufacturing of APIs as part of their additional revenue stream. Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis, and Novartis are dependent on Indian companies for many of their APIs and intermediates.

Today Indian pharma companies have upgraded their existing plants or built new plants which are not only GMP compliant but also approved by international drug authorities. Many mid to large-sized ones have achieved GMP approval of highly regulated markets such as the US, Europe, Australia, Latin America and Canada. The most stringent, the USFDA approval is distributed between large and mid size companies.

India triumphs in having maximum number of USFDA approved plants after the US. India has over 80 USFDA approved plants and all comply with WHO GMP. India is expected to have 30 percent more USFDA plants by 2008. The large portion of this increase will be shared by mid size pharma companies. Most of the companies are upgrading and building new facilities as per USFDA standards. Apart from Andhra Pradesh and Gujarat, Himachal Pradesh is the next favored state for setting up manufacturing plants. India comes fifth in terms of API manufacturing. It has established itself as low cost and high quality API production country. With product patent regime in its second year and several products expected to go off patent in the next 2-3 years, India is well positioned to capture the outsourcing opportunity.

With India emerging as a cost competitive outsourcing base for global majors, Jubilant Organosys, an integrated pharmaceutical and custom research and manufacturing services company, intends to be the preferred partner for custom research and manufacturing to global leaders in the pharmaceuticals and agrochemicals industry.

Jubilant Organosys recently signed a multi-million dollar long-term agreement with Syngenta for the supply of pyridines. The new contract will begin from early 2008 and it will cover an extension period of up to five years, during which Jubilant will continue supplying the products to Syngenta.

Recently Jubilant expanded its production capacity for pyridines and picolines to 42,000 TPA and this contract with Syngenta would significantly improve the use of the additional capacity. With this multi-year contract and increased capacities, Jubilant emerges as the largest player in pyridines worldwide.

Jubilant Organosys have also acquired US-based Hollister–Stier Laboratories LLC for $122.5 million. This is said to be the largest overseas acquisition in contract manufacturing sector by an Indian company. The acquisition significantly strengthens Jubilant's global CRAMS business via entry into the high barrier injectables segment.

Hollister is an excellent strategic fit for Jubilant, as it augments the company's growth in the CRAMS business globally. This acquisition provides Jubilant with a platform within the fast growing injectables contract manufacturing segment.

The company had signed annual contracts worth $60 million. The contracts form part of the company's order book for the calendar year 2007. The contracts have been finalized with some of the leading global life sciences companies in the US and Europe. In addition to these annual contracts, the company as part of its normal business also executes half yearly, quarterly and monthly contracts and spot sales.

The company will also focus on twin strategies of investments in innovation and world-class manufacturing facilities. Currently, Jubilant is in advanced talks with other global life sciences companies and is confident of signing several other contracts for CRAMS over the next few months.

DNA sequencing now made easy and feasible...!!!

Actually when i was planning on gathering the resources for this one, when i was told to go ahead, a friend of mine told me not to, based on my addiction to DNA sequencing and the vast possibilities it can achieve.

Short for deoxyribonucleic acid. The nucleic acid that is the genetic material determining the makeup of all living cells and many viruses. It consists of two long strands of nucleotides linked together in a structure resembling a ladder twisted into a spiral. In eukaryotic cells, the DNA is contained in the nucleus (where it is bound to proteins known as histones) and in mitochondria and chloroplasts. In the presence of the enzyme DNA polymerase and appropriate nucleotides, DNA can replicate itself. DNA also serves as a template for the synthesis of RNA in the presence of RNA polymerase.

recently, we were told that Researchers have devised a nanoscale sensor to electronically read the sequence of a single DNA molecule, a technique that is fast and inexpensive and could make DNA sequencing widely available.

 The technique could lead to affordable personalized medicine, potentially revealing predispositions for afflictions such as cancer, diabetes or addiction. According to the researchers"There is a clear path to a workable, easily produced sequencing platform," said Jens Gundlach, a University of Washington physics professor who leads the research team. "We augmented a protein nanopore we developed for this purpose with a molecular motor that moves a DNA strand through the pore a nucleotide at a time." 

To make it work as a reader, the nanopore was placed in a membrane surrounded by potassium-chloride solution, with a small voltage applied to create an ion current flowing through the nanopore. The electrical signature changes depending on the type of nucleotide traveling through the nanopore. Each type of DNA nucleotide – cytosine, guanine, adenine and thymine – produces a distinctive signature.

The researchers attached a molecular motor, taken from an enzyme associated with replication of a virus, to pull the DNA strand through the nanopore reader. The motor was first used in a similar effort by researchers at the University of California, Santa Cruz, but they used a different pore that could not distinguish the different nucleotide types.

Gundlach is the corresponding author of a paper published online March 25 by Nature Biotechnology that reports a successful demonstration of the new technique using six different strands of DNA. The results corresponded to the already known DNA sequence of the strands, which had readable regions 42 to 53 nucleotides long.

"The motor pulls the strand through the pore at a manageable speed of tens of milliseconds per nucleotide, which is slow enough to be able to read the current signal," Gundlach said.

Gundlach said the nanopore technique also can be used to identify how DNA is modified in a given individual. Such modifications, referred to as epigenetic DNA modifications, take place as chemical reactions within cells and are underlying causes of various conditions.

"Epigenetic modifications are rather important for things like cancer," he said. Being able to provide DNA sequencing that can identify epigenetic changes "is one of the charms of the nanopore sequencing method.
True life story.